FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems: Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
- Recall number
- Z-0438-2008
- Recalling firm
- Aesculap Implant Systems
- Product
- Excia Cemented Hip Stems, Size 11mm, Part Number : NJ311K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
- Status
- Terminated
- Initiated
- 2007-10-10
- Posted
- 2007-12-11
- Terminated
- 2008-02-07
- Reason
- Sterility (package integrity) Compromised: Device package damaged during shipment
- Root cause
- Package design/selection
- Action
- The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.
- Quantity
- 167 units
- Distribution
- Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.
- Lot, serial or model codes
- All Lot Numbers
- 510(k) numbers
- ["K042344"]
- PMA numbers
- not on file
- Product code
- LWJ
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28